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FDA announces new package insert rules

LTC Liability Monitor, January 26, 2006

The U.S. Food and Drug Administration (FDA) unveiled new rules for medication package inserts last week. The FDA hopes to curb the more than 300,000 preventable adverse medication-related events occurring in healthcare facilities every year, an administration press release stated. Under the new regulations, the package inserts must include a "Highlights" section that summarizes the medication's most important benefit and risk information in one place.

The inserts must also provide a table of contents for safety information, the date of the initial product approval, and a toll-free number and Web site for reporting adverse incidents or suspected side effects. The package inserts do not require drug companies to supply any new information, the FDA stated. Pharmacies and drug manufacturers have until June 30 to revise their package inserts for all drugs.

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